ADV Fixation Surgical KIT
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CFR03, 5X100 Kii® OPT ADVFIX 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFR73, 12x100 Kii® OPT ADVFIX 6/BX CFS22, 12x100 Kii® SLEEVE ADVFIX 12/BX…
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CFR03, 5X100 Kii® OPT ADVFIX 6/BX CFS02, 5×100 Kii® SLEEVE ADVFIX 12/BX CFR73, 12×100 Kii® OPT ADVFIX 6/BX CFS22, 12×100 Kii® SLEEVE ADVFIX 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2015-10-16 |
| Record revised | 2021-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K0903 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoplus | Endoplus | 448 |
| Integra® MicroFrance® | Integra Microfrance SAS | 273 |
| Symmetry Surgical® | Aspen Surgical Products, Inc. | 139 |
| Laparoscope, Gynecologic (And Accessories) | Karl Storz GmbH & Co. KG | 119 |
| Elmed | Elmed, Inc. | 96 |
| Olympus | Olympus Winter & IBE Gmbh | 71 |
| Core Dynamics | ConMed Corporation | 52 |
| Symmetry | Aspen Surgical Products, Inc. | 48 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 45 |
| Laparoscope, Gynecologic (And Accessories) | Richard Wolf Gmbh | 37 |
| Take-Apart | Karl Storz GmbH & Co. KG | 31 |
| Blueendo | Trokamed Gmbh | 28 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062169 | 2006-08-24 |
| K040295 | 2004-03-12 |
| K962777 | 1997-08-06 |
| K963359 | 1996-09-24 |
| K945741 | 1995-02-28 |
| K923568 | 1993-12-23 |
| K923636 | 1993-11-05 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-06-25 | Not classified | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). | 14,113 total | 2012-03-26 |
| 2008-06-25 | Not classified | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). | 14,113 total | 2012-03-26 |
| 2008-06-25 | Not classified | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). | 14,113 total | 2012-03-26 |
| 2008-06-25 | Not classified | Process control | Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02). | 14,113 total | 2012-03-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.